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`
`Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status
`Epilepticus (SRSE)
`
`This study has been completed.
`
`Sponsor:
`Sage Therapeutics
`
`Information provided by (Responsible Party):
`Sage Therapeutics
`
`ClinicalTrials.gov Identifier:
`NCT02052739
`First received: January 28, 2014
`Last updated: August 11, 2015
`Last verified: August 2015
`History of Changes
`
`Full Text View
`
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`
`No Study Results Posted
`
`Disclaimer
`
`How to Read a Study Record
`
` Purpose
`The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in subjects in super-refractory status epilepticus (SRSE).
`
`Condition
`Super-refractory Status Epilepticus
`
`Intervention
`Drug: SAGE-547
`
`Phase
`Phase 1
`Phase 2
`
`Interventional
`Study Type:
`Study Design: Endpoint Classification: Safety Study
`Intervention Model: Single Group Assignment
`Masking: Open Label
`Primary Purpose: Treatment
`
`Official Title:
`
`An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SAGE-547 Injection as Adjunctive Therapy for the
`Treatment of Super-Refractory Status Epilepticus
`
`Resource links provided by NLM:
`
`Genetic and Rare Diseases Information Center resources: Status Epilepticus
`
`U.S. FDA Resources
`
`Further study details as provided by Sage Therapeutics:
`
`Primary Outcome Measures:
`Safety and tolerability in subjects in super-refractory status epilepticus (SRSE) [ Time Frame: 29 Days ] [ Designated as safety issue: Yes ]
`Safety will be evaluated via clinical laboratory measures, vitals, EEG and ECG throughout the 29 day study period
`
`Secondary Outcome Measures:
`Efficacy of SAGE-547 on super-refractory status epilepticus as indicated by the need to re-institute a continuous IV AED (third-line agent), for
`refractory seizure control as well as the duration of the observed response [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
`Pharmacokinetics (PK) of SAGE-547 exposure [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
`Plasma PK parameters will be calculated where appropriate (eg, Cmax, Cmin, Tmax, AUClast, AUC∞, CLs). It will be collected prior to, during,
`and after completion of SAGE-547 dosing.
`
`ARGENTUM Exhibit 1132
` Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
`
`Page 00001
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`Enrollment:
`Study Start Date:
`Study Completion Date:
`Primary Completion Date:
`
`25
`January 2014
`June 2015
`June 2015 (Final data collection date for primary outcome measure)
`
`Arms
`Experimental: active drug
`SAGE-547
`
`Assigned Interventions
`Drug: SAGE-547
`Intravenous
`
`Detailed Description:
`This is an open-label study consisting of a Screening period (1 day), 4-day treatment period (96 hours) followed by a 1-day dose taper period (24
`hours), a 2-day acute follow-up period, and a 3 week extended follow-up period.
`On Day 1 of treatment SRSE subjects under seizure suppression or burst-suppression with a continuous IV AED (third-line agent) will be given a 1-
`hour IV loading infusion of SAGE-547 followed by a maintenance infusion. After 48 hours of SAGE-547 treatment, the continuous IV AED (third-line
`agent) will be weaned while continuing SAGE-547 at the maintenance infusion for the remainder of the treatment period. After 96 hours (4 days) of
`therapy with SAGE-547, the dose will be tapered and discontinued over 24 hours.
`The subjects will have routine continuous EEG monitoring during the Screening period, and continuing until 48 hours after SAGE-547 treatment has
`completed. Subjects will then have follow-up examinations weekly for the next 3 weeks (Days 8, 15, 22, and 29), during which safety and functional
`assessments will be obtained. Apart from treatment with SAGE-547, all subjects will receive the standard of care for adults in SRSE along with
`ongoing treatment for all underlying medical conditions.
`
` Eligibility
`
`2 Years and older (Child, Adult, Senior)
`Ages Eligible for Study:
`Both
`Genders Eligible for Study:
`Accepts Healthy Volunteers: No
`
`Criteria
`Inclusion Criteria:
`Subjects 2 years of age and older.
`Subjects with an EEG-confirmed SRSE diagnosis under concomitant therapy with a continuous IV AED (third-line agent) for ≥ 24 hours. For this
`study, SRSE is defined by the following criteria and in accordance with those used at major epilepsy treatment centers:
`Failure to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment),
`according to institution standard of care, and
`Failure to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent
`control AED) according to institution standard of care, and
`Presence of one or more breakthrough seizures > 6 hours after initiation of the continuous IV AED/third-line agent (e.g., pentobarbital,
`midazolam, propofol)
`Exclusion Criteria:
`Subjects with SRSE due to anoxic/hypoxic encephalopathy, children (subjects aged less than 18 years) with an encephalopathy due to an
`underlying progressive neurological disorder.
`Subjects with clinically significant electrocardiogram (ECG) abnormalities.
`Subjects with a significant medical or surgical condition that may compromise vital organ systems, or other conditions that would place the
`subject at increased risk such as dialysis or acute respiratory distress syndrome, severe cardiogenic or vasodilatory shock requiring 2 or more
`pressors, fulminant hepatic failure, etc.
`Subjects who are receiving a continuous IV AED (third-line agent) for seizure suppression or burst-suppression that will require greater than 24
`hours to wean.
`
` Contacts and Locations
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a
`study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general
`information, see Learn About Clinical Studies.
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT02052739
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`Locations
`United States, Alabama
`University of Alabama at Birmingham
`Birmingham, Alabama, United States, 35294
`United States, Florida
`Intercoastal Medical Group
`Sarasota, Florida, United States, 34239
`United States, Illinois
`Ann and Robert H. Lurie Children's Hospital of Chicago
`Chicago, Illinois, United States, 60611
`Northwestern University
`Chicago, Illinois, United States, 60611
`United States, Kansas
`Via Christi Epilepsy Center
`Wichita, Kansas, United States, 67214
`United States, Louisiana
`Ochsner Clinic Foundation
`New Orleans, Louisiana, United States, 70121
`United States, Massachusetts
`Massachusetts General Hospital
`Boston, Massachusetts, United States, 02114
`Brigham and Women's Hospital
`Boston, Massachusetts, United States, 02115
`United States, Michigan
`University of Michigan
`Ann Arbor, Michigan, United States, 48109
`Henry Ford Hospital
`Detroit, Michigan, United States, 48322
`United States, New York
`Columbia University Medical Center
`New York, New York, United States, 10032
`University of Rochester
`Rochester, New York, United States, 14642
`United States, North Carolina
`Duke University Medical Center
`Durham, North Carolina, United States, 27710
`Wake Forest
`Winston-Salem, North Carolina, United States, 27157
`United States, Pennsylvania
`The University of Pennsylvania
`Philadelphia, Pennsylvania, United States, 19104
`United States, Tennessee
`Vanderbilt University Medical Center
`Nashville, Tennessee, United States, 37232
`United States, Texas
`Neurological Clinic of Texas, PA
`Dallas, Texas, United States, 75251
`Baylor Scott & White
`Temple, Texas, United States, 76504
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`Sponsors and Collaborators
`Sage Therapeutics
`
`Investigators
`Study Chair: Stephen J Kanes, M.D., Ph.D. Sage Therapeutics
`
` More Information
`
`Additional Information:
`
`Sage Therapeutics
`
`Sage Therapeutics
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT02052739 History of Changes
`Other Study ID Numbers:
`547-SSE-201
`Study First Received:
`January 28, 2014
`Last Updated:
`August 11, 2015
`Health Authority:
`United States: Food and Drug Administration
`
`Keywords provided by Sage Therapeutics:
`Status Epilepticus
`Refractory status epilepticus
`Super-refractory status epilepticus
`
`Additional relevant MeSH terms:
`Status Epilepticus
`Epilepsy
`Brain Diseases
`Central Nervous System Diseases
`Nervous System Diseases
`
`ClinicalTrials.gov processed this record on November 10, 2016
`
`SAGE-547
`SAGE
`Sage Therapeutics
`
`Page 00004